BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 14739557 · Received June 17, 2022

    Report

    Report Number
    2182207-2022-01121
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    November 19, 2021
    Report Date
    June 17, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H10 CORRECTION: CITATION: WU J, CEVERHA B, YEH BY, BEDELL KK. SUPRASPINAL BACLOFEN FOR THE TREATMENT OF SECONDARY GENERALIZED DYSTONIA: A CASE SERIES. J PEDIATR REHABIL MED. 2022;15(1):145-150.10.3233/PRM-210044. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: WU J, CEVERHA B, YEH BY, BEDELL KK. SUPRASPINAL BACLOFEN FOR THE TREATMENT OF SECONDARY GENERALIZED DYSTONIA: A CASE SERIES. J PEDIATR REHABIL MED. 2022;15(1):145-150.10.3233/PRM-210044 SUMMARY/ABSTRACT: PURPOSE: THE AIM OF THE STUDY WAS TO EVALUATE THE USE OF A NOVEL TECHNIQUE FOR BACLOFEN DELIVERY USING AN INTRATHECAL CATHETER INSERTED THROUGH A LUMBAR LAMINOTOMY WITH THE TIP PLACED AT THE CISTERNA MAGNA (SUPRASPINAL BACLOFEN (SSB)) FOR THE TREATMENT OF SEVERE GENERALIZED SECONDARY DYSTONIA. METHODS: A COHORT STUDY OF SIX INDIVIDUALS (4M/2F, MEAN ± SD = 15 ± 4.86 YEARS) WITH GENERALIZED DYSTONIA UNRESPONSIVE TO ORAL MEDICATIONS WERE TREATED WITH SSB AND FOLLOWED CLINICALLY FOR 9 YEARS. INTRATHECAL CATHETER TIPS WERE POSITIONED UNDER FLUOROSCOPIC GUIDANCE JUST ABOVE THE LEVEL OF THE FORAMEN MAGNUM, AT THE CISTERNA MAGNA. RESULTS: FIVE OF THE 6 PATIENTS EXPERIENCED SUSTAINED BENEFIT WITHSSB; THE GROUP MEAN MODIFIED FAHN-MARSDEN SCALE SCORES DECREASED FROM 95 TO 55 (T = 3.29, P = 0.02). ONE PATIENT SUFFERED COMPLEX PUMP POCKET INFECTION, AND THEREFORE UNDERWENT PUMP EXPLANTATION. CONCLUSION: SUPRASPINAL BACLOFEN MAY BE AN EFFECTIVE METHOD FOR INFUSING BACLOFEN INTO THE VENTRICULAR SYSTEM OF THE BRAIN FOR TREATMENT OF SECONDARY DYSTONIA WHICH IS UNRESPONSIVE TO ORAL THERAPY REPORTED EVENTS: THE PATIENT IN CASE 1 UNDERWENT SSB PUMP PLACEMENT IN THE LAST 3 WEEKS OF A 4-MONTH HOSPITALIZATION FOR MULTIPLE CONCURRENT MEDICAL COMPLICATIONS RELATED TO THEIR DYSTONIA BUT UNRELATED TO THE SSB PUMP AND WAS DISCHARGED TO HOME ON POST-OPERATIVE DAY 19 FOLLOWING COMPLETION OF MEDICAL THERAPIES. THE POST-OPERATIVE COURSE OF THE PATIENT IN CASE 6 WAS NOTABLE FOR INITIAL TACHYCARDIA AND HYPERTENSION WHICH HAD SELF-RESOLVED BY POST-OPERATIVE DAY 5; THEY WERE DISCHARGED TO HOME ON POST-OPERATIVE DAY 8. THE PATIENT IN CASE 1 DIED OF AN UNRELATED CAUSE. AT TIME OF DEATH IN CASE 1, THEY CONTINUED TO DEMONSTRATE BENEFIT FROM SSB WITH CLINICALLY SIGNIFICANT IMPROVEMENT IN DYSTONIA SCORE COMPARED TO PRE-OPERATIVE SCORE. THE PATIENT IN CASE 6 PREVIOUSLY HAD SUBOPTIMAL RESPONSE TO HIGH-DOSE INTRATHECAL BACLOFEN INFUSION WITH THE CATHETER TIP AT T5 IN ADDITION TO HIGH-DOSE ORAL ANTI-SPASTICITY MEDICATIONS. AT THE TIME OF END-OF-BATTERY-LIFE, THE DECISION WAS MADE FOR INTRATHECAL CATHETER TIP REIMPLANTATION TO A SUPRASPINAL LOCATION CONCURRENT WITH PUMP REPLACEMENT, AND THE PATIENT DID WELL. INTERESTINGLY, WHEN THE CATHETER TIP WAS AT T5, THE PATIENT WAS NOTED TO HAVE IMPROVEMENT IN LOWER EXTREMITY SPASTICITY SYMPTOMS AND CONCURRENT WORSENING OF DYSTONIA SYMPTOMS. FOLLOWING REIMPLANTATION OF THE CATHETER TIP FOR SSB INFUSION, THEY WERE SEEN WITH PERSISTENT GOOD CONTROL OF SPASTICITY SYMPTOMS AND IMPROVED CONTROL OF DYSTONIA SYMPTOMS THUS RESULTING IN A DECREASE IN THEIR ORAL ANTI-SPASTICITY MEDICATIONS. AT MAXIMUM THERAPEUTIC BENEFIT, THE PATIENT WAS MAINTAINED AT 586G/DAY SSB WITH SCHEDULED TIZANIDINE 8 MG/DAY. UNFORTUNATELY, THEY SUFFERED BOTH TIP MIGRATION AND PUMP POCKET INFECTION APPROXIMATELY 2 MONTHS FOLLOWING SUPRASPINAL CATHETER TIP RE-IMPLANTATION AND HAD MULTIPLE OPERATIONS FOR WOUND WASHOUT AND REPLACEMENT OF THE PROGRAMMABLE PUMP, WHICH ULTIMATELY FAILED. THE ENSUING POST-OPERATIVE COURSE WAS FURTHER COMPLICATED BY WOUND DEHISCENCE, AND THE PUMP WAS EXPLANTED. THERE WAS ONE PATIENT WHO UNFORTUNATELY HAD MULTIPLE COMPLICATIONS WHICH ULTIMATELY LED TO PUMP REMOVAL. AT 2-MONTHS FOLLOWING REIMPLANTATION OF THE CATHETER TIP ABOVE THE FORAMEN MAGNUM, THE PATIENT IN CASE 6 PRESENTED TO HOSPITAL WITH BACLOFEN WITHDRAWAL. THEY SUBSEQUENTLY HAD MULTIPLE OPERATIONS FOR REPLACEMENT OF THE CATHETER TIP, PUMP POCKET WOUND WASHOUT, AND PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262335 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention